Corporate Sustainability: Products

Quality in Everything We Do

In line with LivaNova’s mission, the Company develops innovative products that deliver life-changing improvements for patients, and the approach to quality starts and ends with patient and customer safety. LivaNova is dedicated to compliance with all laws, standards and regulations regarding quality, safety and performance.

100% of LivaNova manufacturing and R&D facilities are ISO 13485 certified, i.e., the International Organization for Standardization’s quality management system standard for medical devices. LivaNova also complies with all applicable regulations and/or legislations in jurisdictions where we operate, including but not limited to the European medical legislative requirements (Directive 93/42/EEC and Medical Device Regulation 2017/745), the US FDA Quality System Regulations for medical devices (21 CFR part 820), Japan MHLW Ministerial Ordinance No.169, Canadian Medical Device Regulations (SOR/98-282), Brazil ANVISA – RDC No.16/2013, and the Australian Therapeutic Goods (Medical Devices) Regulations 2002 (TGA). In addition, LivaNova manufacturing sites in Italy and Germany are ISO 14001 certified, i.e., the international standard for designing and implementing an environmental management system (EMS). The LivaNova manufacturing site in Italy is also certified ISO 45001, the international standard for the management of the occupational health and safety system.

Our Global Impact


135,000+ PATIENTS treated with VNS Therapy^_TM	40,000+ CHILDREN treated with VNS Therapy^_TM
3.5M+ PATIENTS treated with personalized and proven performance of Inspire^_TM oxygenator	474,000+ NEW PATIENTS treated with Inspire^_TM oxygenator in 2023
50+ YEARS of perfusion know-how and worldwide leadership with S5^_TM HLM and Essenz^_TM Perfusion System	10,000+⁽¹⁾ PATIENTS treated with Essenz^_TM Perfusion System, new product released, demonstrating LivaNova’s commitment of transforming patients outcome with innovative products and therapies
4M+ PATIENTS treated with XTRA^_TM Autotransfusion System	8% increase of PATIENTS treated with XTRA^_TM Autotransfusion System

⁽¹⁾_{Calculated based on number of Essenz^TM Perfusion System installed and considering 1 procedure/day, 4 days/week.}

Facility Compliance

LivaNova sites undergo audits by regulatory authorities and notified bodies on a regular basis, to verify compliance with the regulations in all geographies where the Company distributes products. This includes regular inspections by the US FDA. No Warning Letter was issued to a LivaNova site within the last 3 years.

US FDA WARNING LETTERS ISSUED
	FY21	FY22	FY23
FDA Warning Letters	0	0	0

LivaNova’s Quality Management System

LivaNova’s Quality Management System (QMS) is designed to build quality into products at every stage of the lifecycle, starting from the design and development through manufacturing, testing, distribution, and post-market surveillance.

Employee Training

100% employees responsible for product quality complete training on quality control, product safety and/or QMS. Compliance effectiveness of employee training is monitored and tracked through an electronic training record system.

Supplier Management

100% parts and components not made in-house are sourced from approved suppliers and monitored by LivaNova’s Supplier Quality team. The team is trained to the Company’s rigorous Supplier Quality Process standard which outlines requirements in selecting, qualifying, managing and monitoring suppliers to ensure that all purchased, subcontracted, or otherwise received products and services are controlled and conform to a high-quality standard.
More than 90% of identified high risk, direct material and component suppliers have been audited since 2020 to ensure compliance with LivaNova’s QMS and with applicable regulations. Risk level is determined by the Company’s QMS risk assessment process.
Ongoing engagement and collaboration on process improvements to further drive innovation, sustainability, and patient safety is prioritized. For example, in 2023, LivaNova engaged 100% of identified high risk, direct material and component suppliers to attend workshops for education on the Company’s QMS and production process controls, providing insight into how supplied materials and components impact the Company’s devices and patients.

Product Performance

As part of LivaNova’s Quality Management System (QMS), the Company’s Corrective and Preventative Actions (CAPA) program embeds a robust process to identify potential issues and to take action to resolve. Further, the risk management process follows the ISO 14971 international standard for medical devices which ensures the safety and effectiveness of the devices for the intended use.

LivaNova monitors the use and performance of the products distributed to the market through the post market surveillance system by gathering data from customer feedback collected through the Company’s global complaint handling process and via medical and clinical literature review and post-market clinical data collection activities, with information shared and communicated to customers, patients, and internally via the risk management process. Further, when alerted of potential safety concerns in the market, LivaNova takes immediate actions through the embedded QMS correction and removal process.

Product Performance governance is led by cross-functional leaders from LivaNova’s Medical Affairs, Supplier Quality, and Statistic and Data Science teams.

US FDA RECALLS INITIATED
	FY21	FY22	FY23
FDA Class I Recalls Initiated	0	2	0
FDA Class II Recalls Initiated	2	0	2
FDA Class III Recalls Initiated	2	0	0

Information Security & Privacy

LivaNova endeavors to bring the latest technology to all products in a safe and secure manner. In doing so, the Company strives to integrate both privacy and information security into both products and services. LivaNova is subject to various local and international laws that protect the privacy and confidentiality of certain patient health information, including patient medical records, and that restricts the use and disclosure of patient health information. LivaNova works to comply with various privacy standards and to adapt business processes to ensure that the safety of products and patients’ information remain at the Company’s core.

LivaNova has dedicated resources and processes to help prevent, detect, and respond to cyber threats. The information security team, led by the Chief Information Security Officer (CISO), manages the Company’s Information Security Management System (ISMS) with the objective of strengthening cyber resiliency. LivaNova’s ISMS strengthening plans consider leading industry standards, such as the NIST cybersecurity framework, ISO 27001, COSO, and other security controls to apply across the business.

People

Our employees are crucial in our mission to provide hope and life-changing innovation to our patients and their families.

People Impact

Planet

Our environmental commitment runs from product design through manufacturing and end-of-use disposal and recycling.

Planet Impact

Products

Quality in Everything We Do

Quality in Everything We Do

Our Global Impact

What We Are Doing

Facility Compliance

LivaNova’s Quality Management System

Product Performance

Information Security & Privacy

Facility Compliance

LivaNova’s Quality Management System

Product Performance

Information Security & Privacy

Other Sustainability Focus Areas

People

Planet

Corporate Governance